A presentation by Moses Nkomo Intellectual Property Attorney and Consultant National Workshop on TRIPS and access to medicines in Zimbabwe Holiday Inn, Harare, Zimbabwe 22 January 2014

 Definition of TRIPS Flexibilities  Nature and Scope of TRIPS Flexibilities  Overview of TRIPS Flexibilities incorporated into the Zimbabwean Patents Act  Challenges and opportunities for effective utilisation of TRIPS Flexibilities  Observations from utilisation of Flexibilities  Recommendations

 TRIPS flexibilities” is a term that is used to describe those provisions of the TRIPS Agreement which give member states latitude or flexibility to formulate domestic legislation in a way that balances their international obligations with their national interests.  -mechanisms in the TRIPS Agreement which enable members States to use TRIPS compatible norms in a manner that allows them to pursue their own public policies either in specific fields like access to pharmaceutical products

 1) Transition periods  2) Compulsory licensing  3) Public, non-commercial use of patents  4) Parallel importation  5) Exceptions e.g. research  6) Exclusion from patentability, including exclusion of new uses of known drugs; and  7) Limits on data protection.

 Exclusion from Patentable subject matter – Section 2A  International Exhaustion (Parallel importation) – Section 24A  Test batches (Bolar Exception) – Section 24B  Compulsory licences – Section 30A and 31  Anti-competitive behaviour – Section 31(6a)  Government use - Sections

 According to Section 35(1) of Zimbabwean Patents Act: “During any period of emergency the powers… in relation to an invention by a department of the State shall include the power to make, use, exercise and vend the invention for any purpose which appears to the Minister necessary or expedient - for the maintenance of supplies and services essential to the life of the community; or for securing a sufficiency of supplies and services essential to the well-being of the community”  General notice 240 of 2002 declared a period of emergency due to HIV/AIDS pandemic valid for 6 months  This allowed a person authorized by government to: a) Make or use any patented drug including ARVs; and b) To import any generic drug used in the treatment of HIV/AIDS  Lowered price of AZT/3TC from US$30 per month to US$15 a month

 Act Number 9 of 2002 amended Patents Act  Declaration of Period of Emergency (HIV/AIDS) Notice 2002, General Notice 240 of 2002 – 6 months.  Statutory Instrument 32 of 2003 extended period of emergency for a further 6 years from January 2003 to December  Declaration of Period of Emergency on (HIV/AIDS) Notice, 2009: General Notice Number 49 of 2009 extended period to 2019.